BONE SOLUTIONS, INC.

Address:5712 Colleyville Blvd Ste 210,Colleyville,TX,76034,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Filler, Bone Void, Calcium Compound (MQV) (9) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

Mixing and Delivery System - B4474400000AUX0 Catalog Number : 44-000-00-AUX

Device Description : The Mixing and Delivery System is intended to be used for the delivery of hydrat

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

OsteoCrete® Bone Void Filler - B4474405000BSI0 Catalog Number : 44-050-00-BSI

Device Description : OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. Oste

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Mg OSTEOINJECT® Bone Void Filler - B4474405000INJ0 Catalog Number : 44-050-00-INJ

Device Description : Mg OSTEOINJECT® is an injectable, moldable, and biocompatible Bone Void Filler.

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Mg OSTEOREVIVE® Bone Void Filler - B4474405000REV0 Catalog Number : 44-050-00-REV

Device Description : Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler.

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoCrete® Bone Void Filler - B4474405000STR0 Catalog Number : 44-050-00-STR

Device Description : OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. Oste

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoCrete® Bone Void Filler - B4474410000BSI0 Catalog Number : 44-100-00-BSI

Device Description : OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. Oste

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoCrete® Bone Void Filler - B4474410000BSI1 Catalog Number : 44-100-00-BSI

Device Description : OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. Oste

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Mg OSTEOREVIVE® Bone Void Filler - B4474410000REV0 Catalog Number : 44-100-00-REV

Device Description : Mg OSTEOREVIVE® is an injectable, moldable, and biocompatible Bone Void Filler.

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoCrete® Bone Void Filler - B4474410000STR0 Catalog Number : 44-100-00-STR

Device Description : OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. Oste

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoCrete® Bone Void Filler - B4474415000BSI0 Catalog Number : 44-150-00-BSI

Device Description : OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. Oste

Device Class : 2

Duns Number: 003506272

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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